Ankle SprainNCT01449760
Ankle Sprain Rehabilitation With the Wii Balance Board
A study testing Physical Therapy and Wii Balance Board in people with Ankle Sprain, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Physical activity and in particular sport is beneficial to health. Nevertheless, some of these activities may create a risk of injury. Ankle sprain is the most common sport related injury. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Physical Therapy and Wii Balance Board
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2010to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with an ankle sprain (grad 1 or 2), between 18 and 65 years old,
Who cannot join
- The subjects will not be included in the study if they are under 18 years
- They have other neurological or orthopedic disorders
- If taking medications (other than analgesics +/- NSAIDs prescribed during a sprain) that may influence the measurements.
- The patients with recurrent sprain of the ankle which was less than 12 months or who require surgery were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Physical activity and in particular sport is beneficial to health. Nevertheless, some of these activities may create a risk of injury. Ankle sprain is the most common sport related injury. Sports that are causing the highest number of ankle sprains are: football (30%), handball-basketball-volleyball-rugby (24%), gymnastics sports (6%), skiing (6%), cycling (6%), athletics (4%) and contact sports (4%). A recent study in the Netherlands identified a total of 1.3 million sports injuries. 47% of these patients required medical care. The total costs (direct and indirect) were assessed 84.240.000 EUR per year.
Prospective studies demonstrated that athletes with a ankle sprain have a twofold risk of re-injury during the first year after the trauma, and in half of patients with an ankle sprain recurrence this could lead to instability or chronic pain of the ankle.
Read more
The Wii Balance Board ® is a tool that is increasingly used in the field of health. In some hospitals, therapists are beginning to use it for the rehabilitation of patients after surgery, fractures or strokes.
Patients are asked to complete their physical therapy session by practicing "sports" via video games such as skiing, bowling or hula hoop. Currently, there are no randomized controlled studies that publish on the effectiveness of this tool. Recently, a study investigated the efficacy of the Wii Balance Board ® to improve balance, strength, joint mobility and level of physical activity. After 10 weeks of training, people an increased strength and balance was found. However, these results still require statistical confirmation. Thus this objectives of this study are
- To assess the efficacy of exercise training with the Wii Balance Board ® Platform
- To evaluate the effectiveness of physical therapy (based on current guidelines)
- To compare these two types of care (conventional physiotherapy versus Wii) to a control group (non-treatment).
- Conditions
- Ankle Sprain
- Being tested
- Physical Therapy, Wii Balance Board
- Keywords
- Ankle sprain, Balance, Gait
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
Also called physiotherapy
These patients have a standardized conventional therapy (i.e. 9 sessions of physical therapy over 6 weeks)
Wii Balance BoardOther
These patients get an instruction about how to install and use the Wii Balance Board ®. After the instruction they get the equipment for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | No intervention | Not described |
| Physical Therapy | Active comparator | Not described Receives: Other: Physical Therapy |
| Wii Balance group | Experimental | Not described Receives: Other: Wii Balance Board |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the balance performance(COP displacement in ML and AP direction)
Change in the range of COP displacement during a single leg stance of 30 sec Change in the velocity of COP displacement during a single leg stance of 30 sec
Measured: 6 Weeks after the ankle sprain occured, after treatment (6 weeks) and in a 6 month follow up
Secondary outcomes (1)
Change in several functional parameters
- pain (VAS)
- delay in return to work
- delay in return to sport
- passive joint mobility of the ankle in flexion and extension
- isometric strength of the inverters and evertors, plantar and dorsal flexors
- functional ankle instability evaluated with FAAM questionnaire
- gait parameters (kinematics and electromyographic activity of peroneus, gastrocnemius and tibialis anterior)
- performance during a forwrd jump "monopodal": distance and time to stabilize the ankle
- incidence of recurrent sprains side: 12-month prospective follow-up
Measured: 6 weeks after ankle sprain, after treatment (6 weeks) and 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startMar 2010
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Allet, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449760
- Sponsor's protocol ID
- 09_116
- Status last verified
- Dec 2020
- First submitted
- 5 Oct 2011
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Sprain Rehabilitation With the Wii Balance Board
- ClinicalTrials.gov ID
- NCT01449760
- Acronym / sponsor ID
- 09_116
- Conditions
- Ankle Sprain
- Keywords
- Ankle sprain, Balance, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 10 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physical activity and in particular sport is beneficial to health. Nevertheless, some of these activities may create a risk of injury. Ankle sprain is the most common sport related injury. Sports that are causing the highest number of ankle sprains are: football (30%), handball-basketball-volleyball-rugby (24%), gymnastics sports (6%), skiing (6%), cycling (6%), athletics (4%) and contact sports (4%). A recent study in the Netherlands identified a total of 1.3 million sports injuries. 47% of these patients required medical care. The total costs (direct and indirect) were assessed 84.240.000 EUR per year.
Prospective studies demonstrated that athletes with a ankle sprain have a twofold risk of re-injury during the first year after the trauma, and in half of patients with an ankle sprain recurrence this could lead to instability or chronic pain of the ankle.
The Wii Balance Board ® is a tool that is increasingly used in the field of health. In some hospitals, therapists are beginning to use it for the rehabilitation of patients after surgery, fractures or strokes.
Patients are asked to complete their physical therapy session by practicing "sports" via video games such as skiing, bowling or hula hoop. Currently, there are no randomized controlled studies that publish on the effectiveness of this tool. Recently, a study investigated the efficacy of the Wii Balance Board ® to improve balance, strength, joint mobility and level of physical activity. After 10 weeks of training, people an increased strength and balance was found. However, these results still require statistical confirmation. Thus this objectives of this study are
- To assess the efficacy of exercise training with the Wii Balance Board ® Platform
- To evaluate the effectiveness of physical therapy (based on current guidelines)
- To compare these two types of care (conventional physiotherapy versus Wii) to a control group (non-treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No treatment | No intervention | – |
| Physical Therapy | Active comparator | Other: Physical Therapy |
| Wii Balance group | Experimental | Other: Wii Balance Board |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with an ankle sprain (grad 1 or 2), between 18 and 65 years old,
Key exclusion criteria (4 listed)
- The subjects will not be included in the study if they are under 18 years
- They have other neurological or orthopedic disorders
- If taking medications (other than analgesics +/- NSAIDs prescribed during a sprain) that may influence the measurements.
- The patients with recurrent sprain of the ankle which was less than 12 months or who require surgery were also excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyAlso: physiotherapyThese patients have a standardized conventional therapy (i.e. 9 sessions of physical therapy over 6 weeks) | Other | Physical Therapy |
| Wii Balance BoardThese patients get an instruction about how to install and use the Wii Balance Board ®. After the instruction they get the equipment for 6 weeks. | Other | Wii Balance group |
Primary outcome
Change in the balance performance(COP displacement in ML and AP direction)
Time frame: 6 Weeks after the ankle sprain occured, after treatment (6 weeks) and in a 6 month follow up
Change in the range of COP displacement during a single leg stance of 30 sec Change in the velocity of COP displacement during a single leg stance of 30 sec
1 secondary outcome
Change in several functional parameters
Time frame: 6 weeks after ankle sprain, after treatment (6 weeks) and 6 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy and Wii Balance Board in people with Ankle Sprain, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the balance performance(COP displacement in ML and AP direction) (time frame: 6 Weeks after the ankle sprain occured, after treatment (6 weeks) and in a 6 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.